Healthy Skepticism Library item: 17669

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Publication type: news

Russia passes Pharmaceutical Bill
PM Live 2010 Mar 29
http://www.pmlive.com/find_an_article/allarticles/categories/General/2010/march/news/russia_passes_pharmaceutical_bill

Full text:

Following a majority vote of 393-1 in the lower house of the Duma – Russia’s Parliament – Russia’s new pharmaceutical bill now moves for approval to the upper house and then to the President. It is set to become law by September 1.

The bill aims to replace the existing 12-year-old pharmaceutical law. After much debate, 45 of the originally proposed 312 amendments have been included in the bill. The most controversial plans, such as the suggestion that additional clinical trials for innovative drugs must be conducted in Russia, were dropped.

Its main aims are to improve regulation in the market, to ensure the country’s pharmaceutical industry meets international production standards, to stimulate the domestic industry, to protect the market from counterfeit pharmaceuticals and guarantee affordable prices for consumers, as part of the government’s wider modernisation agenda.

The bill will standardise and stabilise medicine prices, and the government is to set a maximum price on 500 drugs, including those for tuberculosis and diabetes.

Diana Mikhailova, head of the Duma Committee on Pharmaceutical Market Development, commented that: “the pharmaceutical market is not like any other; it has to do with the health of our citizens. That’s why the government must be involved and regulate prices.

“The main aim of the law is that we have quality medicine made by domestic producers,” she added.

Under the bill, registration fees for new drugs in Russia will be cut from RUB 670,000 to RUB 300,000, a move that will be welcomed by both domestic and international companies. In addition, the registration process should take no more than 210 days, considerably less than the current time of up to 18 months, which could see new drugs launch more quickly.

One key aspect of the bill states that by January 1, 2014, every pharmaceutical company operating in Russia must comply with European Good Manufacturing Practice (GMP) standards, and as imports currently account for around 75 per cent of Russia’s pharmaceutical market, it is hoped that this will support the development of competitive domestic drug manufacturing.

According to Russia’s health minister, Tatyana Golikova, only 30 of the 400 pharma companies operating in the country are GMP compliant. The date for compliance has been extended from that proposed in the original version of the bill, which gave a 2012 deadline. Mikhailova has said that the state will assist in the transition to GMP to ensure medicines remain available to consumers during this period. However, analysts estimate that the costs to upgrade could run into billions of dollars.